Case Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery

Not Applicable

Completed

• Conditions: Peripheral Arterial Occlusion or Emboli
• Interventions: Device: Mechanical Thrombectomy by the Indigo System

• Registration Number: NCT02085551
• Lead Sponsor: Penumbra Inc.

Brief Summary

The primary objective of this retrospective case review study is to determine the safety and effectiveness of the Penumbra and Indigo Systems for mechanical thrombectomy in a cohort of patients with confirmed peripheral or visceral arterial occlusion or embolus. This is a retrospective, single arm, multi-center trial. Up to 100 patients at up to 10 centers will be enrolled. Angiographic assessment of vessel patency at immediate post-procedure as measured by TIMI scores and procedural serious adverse events are assessed and recorded.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-12
• Study First Posted: 2014-03-13
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2020-06
• Results First Submitted: 2020-06-03
• Results First Submitted QC: 2020-06-03
• Last Update Submitted: 2020-06-03
• Results First Posted: 2020-06-22
• Last Update Posted: 2020-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• Evidence of a peripheral or visceral arterial occlusion or embolus (TIMI 0-1) prior to treatment.
• Treatment with components of the Penumbra and/or Indigo System.

Exclusion Criteria

• Participation in another clinical investigation that may confound the results of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mechanical thrombectomy by the Indigo System	Mechanical Thrombectomy by the Indigo System	-

Primary Outcome Measures

Name	Time	Method
Angiographic Assessment of Vessel Patency at Immediate Post-procedure as Measured by TIMI Scores	Immediate post-procedure	Proportion of patients with a post-procedure TIMI score of 2 to 3.
Procedural Serious Adverse Events	During the procedure

Trial Locations

Locations (5)

Baptist Health South Florida; 🇺🇸 Miami, Florida, United States

Tri-City Medical Center; 🇺🇸 San Diego, California, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States

Sanford Medical Center; 🇺🇸 Fargo, North Dakota, United States